The GB 9706 Medical Electrical Equipment Standards was issued on April 9, 2020, with the implementation date of May 1, 2023. The NMPA issued the “Notice on Implementation of GB 9706.1-2020 and Supporting Standards” on March 16, 2023, further detailing the implementation timelines and the Grace period for those with existing valid medical device certificates.
The Impact of Medical Electrical Equipment Standards
- Starting from May 1, 2023, for product application submitted for the first time, the testing report that meets the requirements of the new 9706 standards shall be submitted.
- Compliance with mandatory standards is a regulatory requirement. Certified products that are not tested for compliance with the new 9706 standard may face the risk of being disqualified by national inspections.
- The difficulty of submitting products for inspection has increased. Companies must provide risk management documents and other materials that comply with the relevant 9706 standards during the design and development cycles.
Read our comprehensive review on the standard GB 9706.1-2007, equivalent to IEC 60601-1.
Grace Period
For registrations carried out for the GB 9706 testing, an extension period of 3 years is granted. For example:
- If the implementation date of applicable standards is May 1, 2024, the modification registration should be completed before May 1, 2027.
- For products with no applicable standard, or the implementation date of the applicable standard for the product is May 1, 2023, the modification registration shall be completed before May 1, 2026
Inspection Requirements
- The inspection report can be submitted by either entrusted testing institution or registration applicant.
- Entrusted institutions that do not have all the new standard testing qualifications may carry out subcontracted testing.
- For major issues such as basic performance and model typicality, relevant opinions shall be included in the testing report for NMPA’S reference.
What are the New Medical Electrical Equipment Standards?
The new version of GB 9706 standards composes of 69 standards, among them 67 are mandatory standards. They include but are not limited to the following:
- Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Parallel standard: electromagnetic compatibility Requirements and tests
- Medical Electrical Equipment Part 1-8: General Requirements for Basic Safety and Basic Performance Parallel Standards: General Requirements, Testing and Guidelines for Medical Electrical Equipment and Alarm Systems in Medical Electrical Systems
- Medical Electrical Equipment Part 1-11: General Requirements for Basic Safety and Essential Performance Tied Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in Home Care Environments
- Medical Electrical Equipment Part 1-12: General Requirements for Basic Safety and Basic Performance Tied Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Expected to Be Used in Emergency Medical Services Settings
- Medical electrical equipment Part 1-3: General requirements for basic safety and basic performance Parallel standard: radiation protection for diagnostic X-ray equipment
- Safety requirements for electrical equipment for measurement, control and laboratory use Part 4: Special requirements for sterilizers and washer-disinfectors for handling medical materials
- … …
Our Expertise
We have experienced engineers on-site to help you with type testing. We have obtained certificates for many electronic equipment such as:
- CT-accelerator for radiotherapy
- X-ray imaging equipment
- Full Field Digital Mammography systems
- Digital Breast Tomosynthesis Mammography system
- Mammography diagnostic workstation
- RF generator
- Gamma cameras and detector
- Radiotherapy navigator